Paramig Fast Iunior

Leaflet attached to the packaging: information for the user

PARAMIG Fast Junior, 250 mg, granules in a sachet

Paracetamol

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or the patient feels worse, they should contact a doctor.

Table of contents of the leaflet:

• 1. What is Paramig Fast Junior and what is it used for
• 2. Important information before taking Paramig Fast Junior
• 3. How to take Paramig Fast Junior
• 4. Possible side effects
• 5. How to store Paramig Fast Junior
• 6. Contents of the packaging and other information

1. What is Paramig Fast Junior and what is it used for

Paramig Fast Junior contains paracetamol as the active substance. Paracetamol belongs to the pharmacotherapeutic group of analgesics (pain relievers) that also act as antipyretics (fever reducers) with weak anti-inflammatory effects. Paramig Fast Junior is used for the symptomatic treatment of mild to moderate pain and fever. The medicinal product Paramig Fast Junior should not be used for more than three days without a doctor's recommendation.

2. Important information before taking Paramig Fast Junior

When not to take Paramig Fast Junior:

• if the patient is allergic (hypersensitive) to paracetamol or any of the other ingredients of this medicine (listed in section 6),
• if the patient has severe liver failure,
• if the patient has acute liver inflammation,
• if the patient has severe kidney failure,
• if the patient is taking a medicine that has an adverse effect on liver function,
• if the patient has severe hemolytic anemia,
• if the patient is taking MAO inhibitors and for up to 2 weeks after their discontinuation.

Warnings and precautions

Before starting to take Paramig Fast Junior, the patient should discuss it with their doctor or pharmacist if they have:

• liver function disorders, including Gilbert's syndrome (familial hyperbilirubinemia),
• severe kidney or liver function disorders,
• alcoholic disease,
• anorexia, bulimia, or cachexia, prolonged malnutrition,
• low glutathione reserves in the liver, e.g., appetite disorders, cystic fibrosis, HIV infection, starvation, or emaciation,
• dehydration,
• hypovolemia.

You should not exceed the recommended dose of the medicine. It is not recommended to take the medicine for a long time or frequently. You should not take other medicines containing paracetamol at the same time. Taking a multiple of the daily dose at once can cause severe liver damage. In such a case, there is no loss of consciousness, but immediate medical attention is necessary. Prolonged use of the medicine without medical supervision can be harmful. In children treated with paracetamol at a daily dose of 60 mg/kg, it is not justified to administer another antipyretic medicine at the same time, unless the use of paracetamol alone is ineffective. The risk of overdose is higher in people with alcoholic liver damage without cirrhosis. Caution should be exercised in the case of chronic alcoholism. In such a case, the total daily dose should not exceed 2 grams. If the patient is addicted to alcohol or has liver damage, they should not take paracetamol unless prescribed by a doctor. During paracetamol treatment, the patient should not consume alcohol. Paracetamol does not enhance the effects of alcohol. In the event of high fever or symptoms of secondary infection, or if symptoms persist for more than 3 days, the treatment used should be reassessed. If the symptoms worsen or do not improve after 3 days, or if a high fever appears, the patient should consult a doctor. If the patient has severe diseases, including severe kidney or liver function disorders, sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), or malnutrition, chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic), in these situations, patients have been reported to develop a severe disease called metabolic acidosis (a blood and body fluid disorder) when taking paracetamol in regular doses for a longer period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, feeling of nausea (nausea) and vomiting. The total dose of paracetamol should not exceed 3 g per day in adults and children with a body weight of at least 50 kg. If the patient is taking other pain relievers containing paracetamol at the same time, they should not take Paramig Fast Junior without prior consultation with a doctor or pharmacist. You should never take Paramig Fast Junior in a dose larger than recommended. Larger doses do not have a stronger analgesic effect, but they can cause severe liver damage. The first symptoms of liver damage appear after several days. Therefore, it is very important to contact a doctor immediately in case of taking Paramig Fast Junior in a dose larger than recommended in this leaflet. As a result of prolonged or improper use of pain relievers or taking them in large doses, headaches may occur, which should not be treated with higher doses of this medicine. Generally, habitual use of pain relievers, especially combinations of several pain-relieving substances, can lead to permanent kidney damage with a risk of kidney failure (analgesic nephropathy). Sudden discontinuation of the medicine after prolonged, improper use in large doses of pain relievers may cause headaches, weakness, muscle pain, restlessness, and vegetative symptoms. These withdrawal symptoms subside after a few days. Until then, the patient should avoid further use of pain relievers and not restart them without consulting a doctor. The patient should not take Paramig Fast Junior for a long time or in large doses without consulting a doctor or dentist.

Paramig Fast Junior and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, including those that are available without a prescription. Medicines that may interfere with the action of Paramig Fast Junior:

• probenecid, a medicine used to treat gout;
• medicines that can potentially damage the liver, such as phenobarbital (sleeping pills), phenytoin, carbamazepine, primidone (antiepileptic drugs), and rifampicin (used to treat tuberculosis). Taking these medicines and paracetamol at the same time may cause liver damage;
• metoclopramide and domperidone (used to treat nausea). These medicines can accelerate the absorption and onset of action of paracetamol;
• medicines that slow down gastric emptying. These medicines can delay the absorption and onset of action of paracetamol;
• cholestyramine (used to reduce increased lipid levels in serum) may reduce the absorption and delay the onset of action of paracetamol. Therefore, cholestyramine should not be taken within the first hour after paracetamol administration;
• medicines that reduce blood clotting (oral anticoagulants, especially warfarin).

The patient should inform their doctor or pharmacist if they are taking:

• flucloxacillin (an antibiotic), due to the serious risk of blood and body fluid disorders (called metabolic acidosis), which must be treated urgently (see section 2).

Concomitant administration of paracetamol and AZT (zidovudine, a medicine used in HIV infections) increases the tendency to decrease the number of white blood cells (neutropenia), which can disrupt the immune system and increase the risk of infections. Therefore, Paramig Fast Junior can be taken with zidovudine only on the recommendation of a doctor. Repeated intake of paracetamol for more than a week increases the tendency to bleeding. Therefore, long-term use of paracetamol in patients can only be done under medical supervision. Occasional intake of paracetamol does not have a significant effect on the tendency to bleeding.

Effect of paracetamol on laboratory test results

Paracetamol may affect the determination of uric acid and blood sugar levels.

Paramig Fast Junior with food and drink

The patient should not consume alcohol during paracetamol treatment. The patient should not take Paramig Fast Junior after a meal.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor before using this medicine. Pregnancy Paramig Fast Junior can be given to pregnant women if necessary. The patient should use the lowest effective dose for the shortest possible duration. Breastfeeding The medicine passes into breast milk. During breastfeeding, therapeutic doses of this medicine may be used.

Driving and using machines

Paramig Fast Junior does not affect the ability to drive and use machines.

Warnings about excipients

Paramig Fast Junior contains in one sachet:

• 0.64 mg of sucrose. Patients with rare hereditary disorders associated with fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase-isomaltase deficiency should not take this medicine;
• glucose in trace amounts. Patients with glucose-galactose malabsorption syndrome should not take this medicinal product;
• 11.81 mg of aspartame (E 951), which is a source of phenylalanine and may be harmful to people with phenylketonuria, a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion;
• 20.25 mg of glycerol in one sachet. The medicine may cause headache, gastrointestinal disorders, and diarrhea;
• 57.5 mg of sodium in one sachet, which corresponds to 2.9% of the WHO-recommended maximum daily intake of 2 g of sodium for adults. This should be taken into account in patients using a controlled sodium diet.

3. How to take Paramig Fast Junior

Paramig Fast Junior should always be taken exactly as directed in this leaflet. In case of doubt, the patient should consult a doctor or pharmacist. The doses used in children depend on age and body weight. The single dose is 10 mg/kg body weight every 4 hours or 15 mg/kg body weight every 6 hours. The maximum daily dose is 60 mg/kg body weight. The interval between individual doses should not be less than 4 hours. The patient should not take Paramig Fast Junior for more than three days without a doctor's recommendation. The dose is determined based on the information provided in the table below. Sachet 250 mg Body weight (body weight) Single dose Maximum daily dose (age) 17-25 kg 250 mg paracetamol 1000 mg paracetamol (4-8 years) (1 sachet) (4 sachets)

Children from 4 to 8 years old(body weight 17-25 kg)
Single dose 250 mg paracetamol (1 sachet) taken every 4-6 hours. Do not exceed the maximum daily dose of 1000 mg paracetamol (i.e., 4 sachets).
Children from 8 to 12 years old (body weight 26-40 kg)
Single dose 500 mg paracetamol (2 sachets) taken every 4-6 hours. Do not exceed the maximum daily dose of 1500 mg paracetamol (i.e., 6 sachets).
Method of administration Only for oral use. The granules should be taken directly into the mouth (on the tongue) and swallowed without drinking water. The granules dissolve instantly in the mouth, and the mild effervescent effect of the medicinal product causes increased saliva production, making it easier to swallow. The patient should not take Paramig Fast Junior after a meal.
Special patient groups
Children
Paramig Fast Junior should not be used in children under 4 years of age or with a body weight below 17 kg. For this group of children, other paracetamol preparations with a different form and strength are available.
Elderly patients
No dose adjustment is required in elderly patients.
Patients with kidney or liver function disorders
In patients with kidney or liver function disorders, the dose should be reduced or the intervals between consecutive doses prolonged. The patient should consult a doctor or pharmacist.
Chronic alcoholism
Chronic alcohol consumption may lower the toxicity threshold of paracetamol. In these patients, the time interval between two doses should be at least 8 hours. The patient should not exceed the dose of 2 g of paracetamol per day.

Using a higher than recommended dose of Paramig Fast Junior

In case of an overdose of Paramig Fast Junior, the patient should contact a doctor or emergency department. Overdose has very serious consequences and can even lead to death.

It is necessary to start treatment immediately, even if the patient feels well, due to the risk of delayed severe liver damage. Symptoms may be limited to nausea or vomiting and may not reflect the severity of the overdose or the risk of organ damage.

organs.

Missing a dose of Paramig Fast Junior

The patient should not take a double dose to make up for a missed dose.
In case of any further doubts about taking the medicine, the patient should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Paramig Fast Junior can cause side effects, although not everybody gets them.
If the following symptoms occur, the patient should stop the treatment and contact a doctor immediately:

• occurring rarely (may affect less than 1 in 1,000 people):
• itching, rash, sweating, petechiae, angioedema (swelling of the face, lips, throat, difficulty breathing), urticaria, edema,
• bleeding,
• abdominal pain, diarrhea, nausea, vomiting, liver failure, liver necrosis, jaundice,
• acute and chronic pancreatitis (severe abdominal pain, vomiting, bloating, fever, muscle pain, diarrhea, itching),
• occurring very rarely (may affect less than 1 in 10,000 people):
• severe skin reactions (pustular rash all over the body or ulcers in the mouth, eyes, genitals, and skin, red spots on the body, often in the center of blisters, bursting blisters, large peeling skin patches, weakness, fever, and joint pain).
• occurring with an unknown frequency (cannot be estimated from the available data):
• a serious condition that can cause acidification of the blood (so-called metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).

Other side effects occurring rarely (may affect less than 1 in 1,000 people):

• anemia,
• non-hemolytic anemia and bone marrow suppression,
• thrombocytopenia (reduced platelet count, bleeding from the nose and gums, bruising),
• kidney disease.

Paracetamol is a widely used medicine, and reports of side effects are rare and usually related to overdose. Nephrotoxic effects are rare and have not been reported to be related to therapeutic doses, except in cases of prolonged use of the medicine. If the patient experiences any worsening of side effects or any side effects not listed in this leaflet, they should inform their doctor or pharmacist.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181C, 02-222 Warsaw tel.: +48 22 49 21 301, fax: +48 22 49 21 309 website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Paramig Fast Junior

Paramig Fast Junior should not be used after the expiry date stated on the sachet and the carton (marked as EXP). The expiry date refers to the last day of the given month. There are no special precautions for the storage of the medicinal product. The medicine should be stored out of sight and reach of children. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Paramig Fast Junior contains

1 sachet contains 250 mg of paracetamol (Paracetamolum) as the active substance. Other ingredients of the medicine: ethylcellulose, hypromellose, macrogol 400, calcium carbonate, sodium bicarbonate, citric acid, sodium dihydrogen citrate, aspartame (E 951), glycerol distearate (E 422) type I, mannitol, sodium croscarmellose, sodium carboxymethylcellulose type A, silicon dioxide, flavor and aroma masking substance (501482 TP0424) containing natural flavoring preparations, identical natural flavoring substances, maltodextrin, sucrose, aspartame (E 951), acesulfame potassium (E950); lemon flavor (502336 TP0551) containing natural flavoring preparations, synthetic flavoring substances, maltodextrin, and alpha-tocopherol (E 307).

What Paramig Fast Junior looks like and what the pack contains

Packaging in the form of a sachet; polyester/aluminum/polyethylene (LDPE). White to yellowish-white granules with a lemon aroma. The collective packaging contains 12 or 24 sachets in a carton. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Synoptis Pharma Sp. z o.o. ul. Krakowiaków 65 02-255 Warsaw Tel.: 22 321 62 40

Manufacturer:

Zinereo Pharma, S.L.U. A Relva s/n, O Porriño 36410 Pontevedra Spain Farmalider S.A. C/Aragoneses, 2 28108 Alcobendas (Madrid) Spain Edefarm S.L. Poligono Industrial Enchilagar del Rullo 117 46191 Vilamarxant Spain

Date of last revision of the leaflet: